EP4176909A1 - Milchpumpensystem - Google Patents

Milchpumpensystem Download PDF

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Publication number
EP4176909A1
EP4176909A1 EP22215655.6A EP22215655A EP4176909A1 EP 4176909 A1 EP4176909 A1 EP 4176909A1 EP 22215655 A EP22215655 A EP 22215655A EP 4176909 A1 EP4176909 A1 EP 4176909A1
Authority
EP
European Patent Office
Prior art keywords
milk
breast
housing
container
pump
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP22215655.6A
Other languages
English (en)
French (fr)
Inventor
Jonathan O'TOOLE
Adam ROLLO
Andrew Carr
Benjamin Levy
Jack COGGINS
Clare ROSS
Rebecca POOLE
Nestor PESTANA
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Chiaro Technology Ltd
Original Assignee
Chiaro Technology Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=63013055&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP4176909(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from GBGB1709566.2A external-priority patent/GB201709566D0/en
Priority claimed from GBGB1709561.3A external-priority patent/GB201709561D0/en
Priority claimed from GBGB1709564.7A external-priority patent/GB201709564D0/en
Priority claimed from GBGB1809036.5A external-priority patent/GB201809036D0/en
Application filed by Chiaro Technology Ltd filed Critical Chiaro Technology Ltd
Publication of EP4176909A1 publication Critical patent/EP4176909A1/de
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/06Milking pumps
    • A61M1/062Pump accessories
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/06Milking pumps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/06Milking pumps
    • A61M1/062Pump accessories
    • A61M1/064Suction cups
    • A61M1/066Inserts therefor
    • AHUMAN NECESSITIES
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    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/06Milking pumps
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    • A61M1/067Pump accessories with means for hands-free operation
    • AHUMAN NECESSITIES
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    • A61M1/06Milking pumps
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    • A61M1/0693Means for improving milking yield with programmable or pre-programmed sucking patterns
    • A61M1/06935Means for improving milking yield with programmable or pre-programmed sucking patterns imitating the suckling of an infant
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    • A61M1/0697Means for improving milking yield having means for massaging the breast
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
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    • A41WEARING APPAREL
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    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
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    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3379Masses, volumes, levels of fluids in reservoirs, flow rates
    • A61M2205/3389Continuous level detection
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    • A61M2205/3546Range
    • A61M2205/3553Range remote, e.g. between patient's home and doctor's office
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    • A61M2205/35Communication
    • A61M2205/3576Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3584Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using modem, internet or bluetooth
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M2205/36General characteristics of the apparatus related to heating or cooling
    • A61M2205/3606General characteristics of the apparatus related to heating or cooling cooled
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
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    • A61M2205/52General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient
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Definitions

  • a breast pump system is a mechanical or electro-mechanical device that extracts milk from the breasts of a lactating woman.
  • the suction generating device is a large component that connects to mains power to operate the pumps therein.
  • Milk collection bottles are provided to store the expressed breast milk.
  • a single bottle with tubing connecting to each breast shield may also be used. But for a mother to use this discretely, such as in an office environment, specialised bras must be used.
  • breast-pumping bras which have a central slit, for the nipple tunnel of the breast shield to extend through, are typically used. The breast shield is held within the bra, with the suction generating device and milk bottle outside the bra.
  • the breast pump system includes a motor driven vacuum pump and power source.
  • An annular (or punctured disc) membrane is provided, with the flow path of the milk going through the centre of the annulus.
  • the membrane is housed in separate housing and is sealed at its inner and outer edges.
  • the breast shield has a small protrusion to engage with these housing components.
  • the design of this breast pump system results in a number of problems.
  • the use of an annular membrane, with the fluid flow path running through the opening of the annulus is undesirable as it results in a large and bulky device. There is therefore a need for improved integrated breast pump systems.
  • An implementation of the invention is a breast pump system that is, at least in part, wearable inside a bra.
  • the breast pump system comprises a breast shield for engagement with the user's breast, a housing for receiving at least a portion of the breast shield and a detachable rigid milk collection container attachable, in use, to a lower face of the housing and connected to the breast shield for collecting milk expressed by the user, with a milk-flow pathway defined from an opening in the breast shield to the milk collection container.
  • the housing inside also includes a pump for generating a negative pressure in the breast shield, as well as battery and control electronics Unlike other wearable breast pumps, the only parts of the system that come into contact with milk in normal use are the breast shield and the milk container; milk only flows through the breast shield and then directly into the milk container. Milk does not flow through any parts of the housing at all, for maximum hygiene and ease of cleaning.
  • the assembled breast pump system 100 includes a housing 1 shaped to substantially fit inside a bra.
  • the housing 1 includes one or more pumps and a rechargeable battery.
  • the breast pump system includes two parts that are directly connected to the housing 1: the breast shield 7 and a milk container 3.
  • the breast shield 7 and the milk container 3 are directly removable or attachable from the housing 1 in normal use or during normal dis-assembly (most clearly shown in Figure 5 ). All other parts that are user-removable in normal use or during normal dis-assembly are attached to either the breast shield 7 or the milk container 3.
  • the breast shield 7 and milk container 3 may be removed or attached for example using a one click or one press action or a push button or any other release mechanism. Audible and/or haptic feedbacks confirm that the pump is properly assembled.
  • the modularity of the breast pump allows for easy assembly, disassembly and replacement of different parts such as the breast shield and milk collection container. This also allows for different parts of the pump to be easily washed and/or sterilised.
  • the breast shield and bottle assembly both of which are in contact with milk during pumping, may therefore be efficiently and easily cleaned; these are the only two items that need to be cleaned; in particular, the housing does not need to be cleaned.
  • the housing 1, breast shield 7 that is holding a flexible diaphragm, and milk container 3 attach together to provide a closed-loop pneumatic system powered by piezoelectric pumps located in the housing 1. This system then applies negative pressure directly to the nipple, forms an airtight seal around the areola, and provides a short path for expressed milk to collect in an ergonomically shaped milk container 3.
  • Self-sealing enables simple components to be assembled together with a light push: for example, the diaphragm just needs to be placed lightly against the diaphragm housing; it will self-seal properly and sufficiently when the air-pump applies sufficient negative air-pressure.
  • the diaphragm itself self-seals against the housing when the breast shield is pushed into the housing.
  • the breast shield self-seals against the milk container when the milk container is pushed up to engage the housing. This leads to simple and fast assembly and dis-assembly, making it quick and easy to set the device up for use, and to clean the device after a session.
  • Self-sealing has a broad meaning and may also relate to any, wholly or partly self-energising seals. It may also cover any interference seals, such as a press seal or a friction seal, which are achieved by friction after two parts are pushed together.
  • the breast pump system 100 is small enough to be at least in part held within any bra without the need to use a specialized bra, such as a maternity bra or a sports bra.
  • the rear surface of the breast pump is also concave so that it may sit comfortably against the breast.
  • the weight of the system has also been distributed to ensure that the breast pump is not top heavy, ensuring comfort and reliable suction against the breast.
  • the centre of gravity of the pump system is, when the container is empty, substantially at or below the horizontal line that passes through the filling point on the breast shield, so that the device does not feel top-heavy to a person while using the pump.
  • the centre of gravity is substantially at or below the half-way height line of the housing so that the device does not feel top-heavy to a user using the pump.
  • the centre of gravity of the breast pump is at around 60mm high on the centreline from the base of the breast pump when the milk container is empty.
  • the centre of gravity lowers, which increases the stability of the pump inside the bra. It reduces to around 40mm high on the centreline from the base of the breast pump when the milk container is full.
  • the centre of gravity of the breast pump is at about 5.85mm below the centre of the nipple tunnel when the milk container is empty, and reduced to about 23.60mm below the centre of the nipple tunnel when the milk container is full.
  • the centre of gravity should be at least 2mm below the centre of the nipple tunnel when the container is empty.
  • the user interface 5 comprises power button 5A for turning the pump on and off.
  • the user interface 5 further comprises pump up button 5B and pump down button 5C. These buttons adjust the pressure generated by the pump and hence the vacuum pressure applied to the user's breast.
  • the pump up button 5B could be physically larger than the pump down button 5C.
  • a play/pause button 5D is provided for the user to interrupt the pumping process without turning the device off.
  • the housing 1 and milk collection container 3 form a substantially continuous outer surface, with a generally convex shape. This shape roughly conforms with the shape of a 'tear-drop' shaped breast. This allows the breast pump 100 to substantially fit within the cup of a user's bra.
  • the milk collection container 3 is retained in attachment with the housing 1 by means of a latch system, which is released by a one-click release mechanism such as a push button 2 or any other one-handed release mechanism.
  • An audible and/or haptic feedback may also be used to confirm that the milk collection container 3 has been properly assembled.
  • the European standard EN 13402 for Cup Sizing defines cup sizes based upon the bust girth and the underbust girth of the wearer and ranges from AA to Z, with each letter increment denoting an additional 2 cm difference. Some manufacturers do vary from these conventions in denomination, and some maternity bras are measured in sizes of S, M, L, XL, etc.
  • the breast pump 100 of the present invention corresponds to an increase of between 3 or 4 cup sizes of the user according to EN 13402.
  • a plane-to-plane depth of the breast pump can also be defined. This is defined as the distance between two parallel planes, the first of which is aligned with the innermost point of the breast pump 100, and the second of which is aligned with the outermost point of the breast pump 100. This distance is preferably less than 100 mm.
  • FIG 2 is a rear view of the breast pump 100 of Figure 1 .
  • the inner surface of the housing 1 and milk collection container 3 are shown, along with a breast shield 7.
  • the housing 1, milk collection container 3 and breast shield 7 form the three major subcomponents of the breast pump system 100. In use, these sub-components clip together to provide the functioning breast pump system 100.
  • the breast shield 7 is designed to engage with the user's breast, and comprises a concave inner flange 7A which contacts the breast. To allow the breast pump 100 to be used on either of the user's breasts, the breast shield 7 is preferably substantially symmetrical on its inner flange 7A.
  • the breast shield is the only component which contact's the wearer's breast. This leaves fewer surfaces which require thorough cleaning as it reduces the risk of milk contacting a part of the device which cannot be easily sterilized. Additionally, this also helps to disperse the pressure applied to the user's breast across a larger area.
  • the breast shield 7 substantially aligns with the outer edge 1B of the housing 1.
  • the milk collection container 3 may be provided with an arcuate groove for receiving a lower part of the breast shield 7. This is best shown in later Figures. In the assembled arrangement of Figures 1 and 2 , the inner surface of the breast pump 100 is substantially continuous.
  • the breast shield 7 comprises a shield flange for engaging the user's breast, and an elongate nipple tunnel 9) aligned with the opening and extending away from the user's breast.
  • Breast shield nipple tunnel 9 extends from a curved section 7B in the breast shield 7.
  • the nipple tunnel 9 is integral with the breast shield 7.
  • Curved section 7B is positioned over the user's nipple and areola in use.
  • the breast shield 7 forms an at least partial seal with the rest of the user's breast around this portion, under the negative air pressure created by an air-pressure pump.
  • This breast shield nipple tunnel 9 defines a milk-flow path from the inner surface of the breast shield 7A, through the breast shield nipple tunnel 9 and into the milk collection container 3.
  • the breast shield nipple tunnel 9 is preferably quite short in order to minimise the length of the milk-flow path in order to minimise losses.
  • the device is also reduced in size and complexity of small intermediate portions.
  • the breast shield nipple tunnel 9 may extend less than 70 mm from its start to end, more preferably less than 50 mm.
  • the nipple tunnel 9 is substantially aligned with the user's nipple and areolae.
  • the nipple tunnel comprises a first opening 9A for depositing milk into the collection container and a second opening 19A for transferring negative air pressure generated by the pump to the user's nipple.
  • the shield flange 7A and nipple tunnel 9 may be detachable from the housing 1 together.
  • the shield flange 7A and nipple tunnel 9 being detachable together helps further simplify the design, and reduce the number of components which must be removed for cleaning and sterilization.
  • the nipple tunnel 9 will be integral with the breast shield 7, in order to simplify the design and reduce the number of components which must be removed for cleaning and sterilisation.
  • FIGS 3 and 4 are of a partially disassembled breast pump 100 of the present invention.
  • the breast shield 7 has been disengaged from the housing 1 and milk collection bottle 3.
  • the housing 1 comprises a region or slot 11 for receiving the breast shield nipple tunnel 9 of the breast shield 7.
  • the breast shield is held in place thanks to a pair of channels (9B) included in the nipple tunnel 9, each channel including a small indent.
  • channels (9C) engage with the channels, guiding the housing into position; a small, spring plunger, such as ball bearing in each ridge facilitates movement of the housing on to the nipple tunnel 9.
  • the breast shield 7 may also be held in place by means of a clip engaging with a slot located on the housing.
  • the clip may be placed at any suitable point on the shield 7, with the slot in a corresponding location.
  • the breast pump 100 further comprises a barrier or diaphragm for transferring the pressure from the pump to the milk-collection side of the system.
  • this includes flexible rubber diaphragm 13 seated into diaphragm housing 19A.
  • the barrier could be any other suitable component such as a filter or an air transmissive material.
  • Diaphragm housing 19A includes a small air hole into the nipple tunnel 9 to transfer negative air pressure into nipple tunnel 9 and hence to impose a sucking action on the nipple placed in the nipple tunnel 9.
  • the milk-flow pathway extends beneath or under the barrier 13 or surface of diaphragm housing 19A. This provides an added benefit of having gravity move the milk down and away from the barrier.
  • a spout may be provided to attach to the protrusion 31A for ease of pouring.
  • a cap may also be provided to attach to the protrusion 31A in order to seal the milk collection bottle 3 for easy storage.
  • the pouring spout, drinking spout, teat or cap may also be integral to the milk collection container.
  • FIGS 7 and 8 show front views of a breast pump system 100.
  • the outer-surface of the housing 1 has been drawn translucent to show the components inside.
  • the control circuitry 71 for the breast pump 100 is shown in these figures.
  • the control circuitry in the present embodiment comprises four separate printed circuit boards, but it is appreciated that any other suitable arrangement may be used.
  • the diaphragm 13 transmits this negative air pressure to its opposite side (denoted the milk-flow side 13A).
  • This negative pressure is transferred through a small opening in the diaphragm housing 19A to the breast shield nipple tunnel 9 and the curved opening 7B of the breast shield 7 that contacts the breast.
  • This acts to apply the pressure cycle to the breast of the user, in order to express milk.
  • the milk is then drawn through the nipple tunnel 9, to the one way valve 37 that remains closed whilst negative pressure is applied.
  • the valve 37 opens and milk flows under gravity past the valve 37 and into milk container 3.
  • Negative air pressure is periodically (e.g. cyclically, every few seconds) applied to deliver pre-set pressure profiles such as profiles that imitate the sucking of a child.
  • the other opening 99 is a milk opening 99.
  • the milk opening 99 is provided on a lower surface 93B of the separation chamber 93 and connects in use to the container 3. After flowing through the tortuous breast shield nipple tunnel 9 pathway, the milk is encouraged to flow through this opening 99 into the container 3. This is further aided by the transverse nature of the upper surface 93A. In this manner, expressed milk is kept away from the diaphragm 13.
  • the breast pump 100 can be separated into a "air" side comprising the pump 83, the connection spout 85 and the pumping side 13B of the diaphragm 13 and a "milk-flow" side comprising the breast shield 7, the milk collection container 3 and the milk-flow side 13A of the diaphragm 13.
  • any suitable structure to transmit air pressure while isolating either side of the system may be used.
  • Figure 10 shows a schematic of a basic pneumatic system 200 for a breast pump 100.
  • milk expressed into the breast shield 7 is directed through the breast shield nipple tunnel 9 through the torturous air-liquid labyrinth interface 95.
  • the milk is directed through the non-return valve 37 to the collection container 3.
  • This side of the system forms the "milk-flow" side 201.
  • the air exhaust 83B may be used for functions including, but not limited to, cooling of electrical components, inflation of the bottle to determine milk volume (discussed further later) or inflation of a massage bladder or liner against the breast.
  • This massage bladder may be used to help mechanically encourage milk expression. More than one massage bladder may be inflated regularly or sequentially to massage one or more parts of the breast.
  • the air pump may be used to provide warm air to one or more chambers configured to apply warmth to one or more parts of the breast to encourage let-down.
  • FIG. 11 shows an alternative pneumatic system 300.
  • the core architecture of this system is the same as the system shown in Figure 10 .
  • the pump 83 has the option of applying negative pressure directly to the pressure sensor 101. This allows repeated testing of the pump in order to calibrate pump systems, or to diagnose issues with the pump in what is called a dead end stop test. This is achieved by throwing the valve to connect the pump 83 to the dead end 113. The pump 83 then pulls directly against the dead end 113 and the reduction of pressure within the system can be detected by the pressure sensor 101.
  • the pressure sensor detects when pressure is delivered and is then able to measure the output of the pumping mechanism.
  • the results of the pressure sensor are then sent to an external database for analysis such as a cloud database, or are fed back to an on-board microcontroller that is located inside the housing of the breast pump system.
  • the profiles can also be manually adjusted by the user using a control interface on the housing of the breast pump system or on an application running on a connected device.
  • the system stores the user-indicated comfort levels together with associated parameters of the pumping system.
  • the pressure profiles may then be fine scaled in order to provide the optimum comfort level for a particular user.
  • the pressure profiles or any of the pumping parameters may also be dynamically adjusted depending on the real time milk expression rate or quantity of milk collected.
  • the pressure profiles or any of the pumping parameters may also be dynamically adjusted when the start of milk let-down has been detected.
  • the correct sizing of the breast shield and the alignment of the nipple in the breast shield are key for an efficient and comfortable use of the breast pump.
  • breast shape, size as well as nipple size and position on the breast vary from one person to another and one breast from another.
  • women's bodies often change during the pumping life cycle and consequently breast shield sizing may also need to be changed. Therefore, a number of breast shield sizes are available.
  • Guide lines for correct nipple alignment are also provided.
  • the user When the nipple is correctly aligned, the user then rotates the breast shield in order for the diaphragm to be positioned on top of the nipple.
  • the user may then quickly assemble the rest of the breast pump (i.e. the housing and the milk container) on the breast shield via a one-click attachment mechanism confirming correct engagement, which may be performed one-handed.
  • Nipple alignment may therefore be easily maintained. Audio and/or haptic feedback may also be provided to further confirm correct engagement.
  • live data can be used to automatically and intelligently affect specific pumping parameters in order to produce the most efficient pumping session. For example, if the rate of expression increases, the milking cycle might be adjusted accordingly to achieve a more efficient, or more comfortable pumping cycle.
  • the controller 278 calculates a series of intensity ratios IE1:IR1; IE2:IR2...IEn:IRn, which are then used to determine the level of the liquid inside the container.
  • the intensity ratio of IE1:IR1 is the same as IE2:IR2, given the optical emitters 273 are equidistant from the optical receiver 274, this indicates that the level of the liquid inside the container is parallel to the top of the bottle, as shown in Figure 27 .
  • these two intensity ratios are different, this indicates that the liquid level is at a different angle, such as that shown in Figure 28 .
  • the optical emitters 273 may also each emit radiation at different times, such to allow the controller 278 to more easily process the signals from the optical receiver 274, and more easily distinguish between the radiation emitted by each of the optical emitters 273.
  • the device 270 herein described is preferably powered by a battery or some other power source located in the device 270. In other embodiments, the device 270 may be powered using mains electricity.
  • the container is an industrially sized milk tank, which only includes a single laser mounted at the top of the tank. Whilst this apparatus is suited for large-sized containers, which do not move in use, the apparatus is less-suited for applications where the container moves in use, or where the liquid level inside the container is non perpendicular to the laser beam shone into the container.
  • the sensor module described above can be used in a variety of different applications, is conveniently located within a housing, and which by virtue of it having at least two optical emitters, can determine the level of liquid even inside containers of irregular shapes, and which can determine the level of liquid inside a container irrespective of the orientation of the liquid level inside the container.
  • It relates to a system allowing a user to quickly and simply adjust the cup size of a maternity bra to allow discrete and comfortable insertion and use of an integrated wearable breast pump.
  • the user does not need a specialised adjustable bra; instead the present system works with all conventional maternity bras.
  • the user also does not have to purchase any larger bras to wear while pumping.
  • the cups 329 may be stitched to the bra band 321. At least one of the cups 329, is in detachable attachment with the corresponding strap 321. In particular, this is achieved at attachment point 330 where a hook 331 attached to the bra strap 321 engages with a clasp 331 attached to the cup 329.
  • the hook 331 and the bra strap adjuster 325 are set such that in the closed position, the cup size of the bra 320 fits the wearer's breasts.
  • the detachable attachment point 330 may be provided at a different location, such as at the attachment between the bra band 322 and the cup 329.
  • the mechanism for such an attachment point is the same as described above.
  • Figure 33 depict a clip 335 according to the present invention, along with a clasp 332 shown in isolation from the bra cup 329 it is normally attached to.
  • the clip comprises a first engagement mechanism and at least one second engagement mechanism(s).
  • the clip is attachable in a releasable manner to the support structure at a first position via the first engagement mechanism and attachable in a releasable manner to one of the partially detachable cups via the second engagement mechanism to provide a second cup size different to the first cup size.
  • the clip 335 is provided with a material pathway 336 which receives a portion of the bra strap 321.
  • the clip 335 is substantially U-shaped, with a narrowing profile towards its open end.
  • Figure 33 (c) shows the clip 335 being attached to a bra strap 321 in order to provide a second attachment point 337 for the clasp 332 to attach to, and hence to provide a second cup size for the bra 320.
  • the clip 335 is attached in a portion of strap 321A below the original attachment point 330 and hence the second attachment point 337 is likewise below the original attachment point. This results in a second cup size larger than the first cup size.
  • the clip 335 engages with the support structure in a direction transverse to the direction in which it engages with the cup.
  • the attachment clip could be provided on the second, centremost prong 342B.
  • the centremost prong 342B would be on the outside of the bra, with the first and third prongs 342A, 342C on the inside.
  • the first engagement mechanism engages with the support structure in a first direction and the second engagement mechanism engages with the cup in a second direction transverse to the first direction.
  • the second engagement mechanism may be one or more of a hook or a snap or a clip. This ensures easy interfacing with the traditional hook and clasp systems already provided on maternity bras.
  • the clip comprises a material pathway with an opening for receiving a portion of the support structure as the first engagement mechanism for securing the clip to the bra.
  • the clip may substantially U-shaped, and the material pathway is between the arms of the U.
  • the method further comprises the steps of: detaching the first engagement mechanism of the clip from the first position support structure of the maternity bra; attaching the first engagement mechanism of the clip in a releasable manner to a second position of the support structure of the maternity bra; and attaching the other of the detachable cups to the second engagement mechanism of the clip in a releasable manner to provide a second cup size different to the first cup size.
  • detaching the first engagement mechanism of the clip from the first position support structure of the maternity bra
  • attaching the other of the detachable cups to the second engagement mechanism of the clip in a releasable manner to provide a second cup size different to the first cup size.
  • the alternative proposed solution is a small adapter device, which comprises a first portion 370 including a clasp 373 and a second portion 372 including a hook 374, in which the first and second portions are separated by a small distance 371 in order to provide two different adjustable sizes.
  • the first portion includes a clasp 373 that is designed to attach to the hook on the bra strap 321. It may also include a top hook 375 positioned underneath the clasp, and a clip 376 on the rear side.
  • the second portion includes a bottom hook 372.
  • the Elvie breast pump system makes less then 30dB noise at maximum power and less than 25dB at normal power, against a 20dB ambient noise; tests indicate that it makes approximately 24dB noise at maximum power and 22dB at normal power, against a 20dB ambient noise.
  • Piezo pumps also have lower current draw, allowing for increased battery life.
  • a piezo pump is therefore ideally suited for wearable devices with its low noise, high strength and compact size. Further, as shown in the breast pump system of Figures 7 and 8 , more than one piezo pump may be used.
  • piezo mounted either in series or in parallel can also be implemented in any medical wearable devices or any wearable device.
  • the piezo pump may pump air as well as any liquid.
  • a dual configuration is also implemented in which more than one piezo pump is configured such that they can easily switch between a parallel mode and a series mode. This dual configuration would suit wearable devices that would need to achieve either lower or higher pressure faster.
  • a piezo pump may be used in combination with a heat sink in order to efficiently manage the heat produced by the wearable pump. This configuration may be used to ensure that the wearable device can be worn comfortably.
  • the heat sink or heat sinks are configured to ensure that the maximum temperature of any parts of the breast pump system that might come into contact with the skin (especially prolonged contact for greater than 1 minute) are no more than 48°C and preferably no more than 43°C.
  • Feature 3 Elvie is wearable and includes a clear breast shield with nipple guides for easy breast shield sizing
  • Feature 5 Elvie is wearable and includes a breast shield that attaches to the housing with a single push
  • Feature 6 Elvie is wearable and not top heavy, to ensure comfort and reliable suction against the breast
  • a wearable breast pump system including:
  • a breast pump system including:
  • a wearable breast pump system including:
  • Feature 9 Elvie is wearable and collects data to enable the mother to understand what variables (e.g. time of day, pump speed etc.) correlate to good milk-flow
  • Feature 10 Elvie is wearable and collects data that can be exported to social media.
  • a smart bottle or container that includes or is associated with a memory or a tag that is programmed to store the date and time it is filled using data from a pump or a connected device, such as a smartphone.
  • a breast pump system including:
  • Feature 14 Elvie includes a control to toggle between recording whether milk is being expressed from the left breast and the right breast.
  • a wearable breast pump system including:
  • Feature 15 Elvie includes a pressure sensor.
  • a breast pump system including (i) a pumping mechanism that applies negative air-pressure and (ii) a microcontroller programmed to cause the pumping mechanism to deliver various pre-set pressure profiles and to permit the user to manually vary the pressure to a value or values that are in-between the values available from a pre-set pressure profile.
  • Feature 18 Elvie includes a microcontroller to dynamically and automatically alter pump operational parameters
  • a breast pump system including:
  • Feature 22 Elvie uses more than one piezo air pump in series
  • Feature 23 Elvie is wearable and has a piezo air-pump, a breast shield and a diaphragm that fits directly onto the breast shield
  • Feature 24 Elvie is wearable and has a piezo air-pump for quiet operation and a re-useable, rigid milk container for convenience
  • a wearable breast pump system including:
  • Feature 25 Elvie has a piezo-pump for quiet operation and is a connected device
  • a breast pump system including
  • Feature 26 Elvie uses a piezo in combination with a heat sink that manages the heat produced by the pump.
  • a breast pump system including:
  • Feature 27 Elvie is wearable and gently massages a mother's breast using small bladders inflated by air from its negative pressure air-pump
  • a breast pump system including:
  • a breast pump system including:
  • Feature 29 Elvie is wearable and includes a re-useable, rigid milk container that forms the lower part of the pump, to fit inside a bra comfortably
  • a wearable breast pump system configured including:
  • a wearable breast pump system including:
  • Feature 32 Elvie is wearable and includes a removable milk container below the milk flow path defined by a breast shield for fast and reliable milk collection
  • a wearable breast pump system including:
  • a wearable breast pump system including:
  • a wearable breast pump system configured as a single unit and including:
  • Feature 36 Elvie is wearable and includes a milk container that is shaped with broad shoulders and that can be adapted as a drinking bottle that baby can easily hold
  • a wearable breast pump system configured as a single unit and including:
  • Feature 37 Elvie is wearable and includes a light-based system that measures the quantity of milk in the container for fast and reliable feedback
  • the wearable breast pump system includes:
  • a liquid-level measuring system for measuring the quantity of liquid in a container for a breast pump including:
  • a bra adjuster for a nursing or maternity bra including a bra cup with a flap that can be undone to expose the nipple, and the flap attaching to the shoulder strap using a clasp, hook or other fastener attached to the flap, and a corresponding fastener attached to the shoulder strap; and in which the bra adjuster is attachable at one end to the fastener attached to the flap, and at its other end to the fastener attached to the shoulder strap, and hence increases the effective bra cup size sufficiently to accommodate a wearable breast pump, and is also detachable from the flap and shoulder strap.
  • a wearable device including multiple piezo pumps mounted together either in series or in parallel.
  • a wearable medical device including a piezo pump and a heat sink attached together.
  • a wearable breast pump system including:
  • a wearable breast pump system including:
  • a wearable breast pump system including:
  • a wearable breast pump system including:
  • a breast pump system including:
  • a wearable breast pump system including:
  • a breast pump system including:
  • a breast pump system including:
  • a breast pump system including a pumping mechanism and a milk container and including:
  • a wearable breast pump system including:
  • Embodiment 45 A breast pump system including (i) a pumping mechanism that applies negative air-pressure and (ii) an air pressure sensor configured to measure the negative pressure delivered by the negative air-pressure mechanism and (iii) a measurement sub-system that measures or infers milk flow or milk volume.
  • Embodiment 46 A breast pump system including (i) a pumping mechanism that applies negative air-pressure and (ii) a microcontroller programmed to cause the pumping mechanism to deliver various pre-set pressure profiles and to permit the user to manually vary the pressure to a value or values that are in-between the values available from a pre-set pressure profile.
  • Embodiment 48 A breast pump system including (i) a pumping mechanism that applies negative air-pressure and (ii) a microcontroller programmed to automatically change one or more parameters of the pumping mechanism, and to automatically measure or relate milk expression data as a function of different values of one or more of these parameters.
  • Embodiment 49 A breast pump system including (i) a pumping mechanism that applies negative air-pressure and (ii) a microcontroller programmed to dynamically change one or more parameters of the pumping mechanism, and to automatically detect the start of milk let-down.
  • a breast pump system including:
  • a breast pump system including:
  • a wearable breast pump system including:
  • a breast pump system including:
  • a breast pump system including:
  • a breast pump system including:
  • a wearable breast pump system configured including:
  • a wearable breast pump system including:
  • a wearable breast pump system including:
  • a breast pump system including:
  • a wearable breast pump system including:
  • Embodiment 65 A wearable breast pump system configured as a single unit and including:
  • Embodiment 66 A wearable breast pump system configured as a single unit and including:
  • Embodiment 67 A system for milk volume determination, for use as part of a breast pump, or breast milk collecting device, including:
  • Embodiment 68 A liquid-level measuring system for measuring the quantity of liquid in a container for a breast pump; the system including:
  • Embodiment 69 A liquid-level measuring system for measuring the tilt angle of liquid in a container; the system including:
  • Embodiment 70 A bra adjuster system for a nursing or maternity bra, the nursing or maternity bra including a bra cup with a flap that can be undone to expose the nipple, and the flap attaching to the shoulder strap using a clasp, hook or other fastener attached to the flap, and a corresponding fastener attached to the shoulder strap; and in which the bra adjuster is attachable at one end to the fastener attached to the flap, and at its other end to the fastener attached to the shoulder strap, and hence increases the effective bra cup size sufficiently to accommodate a wearable breast pump, and is also detachable from the flap and shoulder strap.
  • Embodiment 71 A wearable device including multiple piezo pumps mounted together either in series or in parallel.
  • Embodiment 72 A wearable medical device including a piezo pump and a heat sink attached together.
  • Embodiment 73 The system of any preceding Embodiment in which the only parts of the system that come into contact with milk in normal use are a breast shield and a milk container.
  • Embodiment 74 The system of any preceding Embodiment in which milk only flows through a breast shield and then directly into a milk container.
  • Embodiment 75 The system of any preceding Embodiment in which a breast shield and a milk container are each pressed or pushed into engagement with the housing.
  • Embodiment 76 The system of any preceding Embodiment in which a breast shield and milk container are each pressed or pushed into a latched engagement with the housing.
  • Embodiment 77 The system of any preceding Embodiment in which there are two user-removable parts, namely a breast shield and milk container, and each is insertable into and removable from the housing using an action confirmed with an audible sound, such as a click.
  • Embodiment 78 The system of any preceding Embodiment in which a breast shield is configured to be rotated smoothly around a nipple inserted into the nipple tunnel to position a diaphragm housing portion of the breast shield at the top of the breast.
  • Embodiment 79 The system of any preceding Embodiment in which a breast shield slides into the housing using guide members.
  • Embodiment 80 The system of any preceding Claim in which the housing is configured to slide onto a breast shield, when the breast shield has been placed onto a breast, using guide members.
  • Embodiment 82 The system of any preceding Embodiment in which a breast shield latches into position against the housing when spring plungers, such as ball bearings, in the housing locate into small indents in the breast shield.
  • Embodiment 83 The system of any preceding Embodiment in which a breast shield latches into position against the housing using magnets.
  • Embodiment 84 The system of any preceding Embodiment in which a breast shield includes or operates with a flexible diaphragm that (a) flexes when negative air pressure is applied to it by an air pump system in the housing, and (b) transfers that negative air-pressure to pull the breast and/or nipple against the breast shield to cause milk to be expressed.
  • Embodiment 86 The system of any preceding Embodiment in which no other parts are removable from the breast shield, apart from the flexible diaphragm.
  • Embodiment 87 The system of any preceding Embodiment in which a milk container attaches to a lower surface of the housing and forms the base of the breast pump system in use.
  • Embodiment 88. The system of any preceding Embodiment in which a milk container is a re-useable milk container that when connected to the housing is positioned to form the base of the housing.
  • Embodiment 89 The system of any preceding Embodiment in which a milk container mechanically or magnetically latches to the housing.
  • Embodiment 90 The system of any preceding Embodiment in which a milk container is released by the user pressing a button on the housing.
  • Embodiment 91 The system of any preceding Embodiment in which a milk container includes a removable cap and a removable valve that is seated on the lid.
  • Embodiment 92 The system of any preceding Embodiment in which in normal use, the milk container is positioned entirely within a bra.
  • Embodiment 94 The system of any preceding Embodiment in which all parts that are user-removable in normal use are attached to either a breast shield or a milk container.
  • Embodiment 95 The system of any preceding Embodiment in which audible or haptic feedback confirms the pump system is properly assembled for normal use with the milk container locked to the housing and the breast shield locked to the housing.
  • Embodiment 96 The system of any preceding Embodiment in which a pumping mechanism is a closed loop negative air-pressure system that applies negative pressure to a region surrounding a woman's breast to pump milk form that breast.
  • a pumping mechanism is a closed loop negative air-pressure system that applies negative pressure to a region surrounding a woman's breast to pump milk form that breast.
  • Embodiment 97 The system of any preceding Embodiment which also includes a control sub-system that combines or relates the air-pressure measurements with the milk flow or milk volume measurements
  • Embodiment 98 The system of any preceding Embodiment in which a control sub-system automatically adjusts the negative air-pressure to give the optimal milk flow or milk volume.
  • Embodiment 99 The system of any preceding Embodiment in which a control sub-system automatically adjusts the negative air-pressure during a pumping session to give the optimal milk flow or milk volume within comfort constraints defined by the user.
  • Embodiment 100 The system of any preceding Embodiment in which an air pressure sensor detects pressure created by the pumping mechanism.
  • Embodiment 101 The system of any preceding Embodiment in which an air pressure sensor is a piezo air pressure sensor.
  • Embodiment 102 The system of any preceding Embodiment in which an air pressure sensor measures the negative air pressure during a normal milk expression session.
  • Embodiment 103 The system of any preceding Embodiment in which an air pressure sensor measures the negative air pressure during a calibration session, and the system uses the results to vary the operation of the pumping mechanism so that it deliver consistent performance over time.
  • Embodiment 104 The system of any preceding Embodiment in which an air pressure sensor measures the negative air pressure during a calibration session, and the system uses the results to vary the operation of the pumping mechanism so that different pumping mechanisms in different breast pump systems all deliver consistent performance
  • Embodiment 105 The system of any preceding Embodiment in which an air pressure sensor measures the negative air pressure during a calibration session, and the system uses the results to determine if the pumping mechanism is working correctly, within tolerance levels.
  • Embodiment 158 A method of expressing and collecting milk, comprising the step of using a system as defined in any preceding Embodiment.

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EP22215655.6A 2017-06-15 2018-06-15 Milchpumpensystem Pending EP4176909A1 (de)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
GBGB1709566.2A GB201709566D0 (en) 2017-06-15 2017-06-15 Breast pump
GBGB1709561.3A GB201709561D0 (en) 2017-06-15 2017-06-15 Bra clip
GBGB1709564.7A GB201709564D0 (en) 2017-06-15 2017-06-15 A liquid level measurement system
GBGB1809036.5A GB201809036D0 (en) 2018-06-01 2018-06-01 Breast Pump System
EP18745660.3A EP3638334B1 (de) 2017-06-15 2018-06-15 Milchpumpensystem
PCT/GB2018/051659 WO2018229504A1 (en) 2017-06-15 2018-06-15 Breast pump system

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EP18745660.3A Division EP3638334B1 (de) 2017-06-15 2018-06-15 Milchpumpensystem

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EP22174446.9A Active EP4066870B1 (de) 2017-06-15 2018-06-15 Milchpumpensystem
EP18745660.3A Active EP3638334B1 (de) 2017-06-15 2018-06-15 Milchpumpensystem

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EP (3) EP4176909A1 (de)
JP (2) JP7335234B2 (de)
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AU (1) AU2018283715B2 (de)
CA (1) CA3066971A1 (de)
DE (5) DE202018006806U1 (de)
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